IMMEDIATE AND PROLONGED EFFECTS OF TEMPOROMANDIBULAR JOINT MOBILIZATION ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN HYPOMOBILE TEMPOROMANDIBULAR JOINT PATIENTS; A RANDOMIZED CONTROLLED TRIAL
To compare the immediate and prolonged effects of temporomandibular joint mobilization on pain, range of motion and functional disability in hypomobile temporomandibular joint patients
Design
Single blind, Randomized controlled trial, superiority analysis of the treatment group
Settings and conduct
University Institute of Physical Therapy, The University of Lahore Teaching Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Aged between 20 and 35 years
• Pain in the region of the Temporomandibular joint and masticatory muscles
• Associated muscles and limited mandibular movement for at least six months
• Complete dentition to provide stable and repeatable base points for jaw measurements.
• Diagnosed by an experienced clinician as suffering from Temporomandibular disorders
• Decreased mandibular opening
Exclusion Criteria
• History of severe head trauma or surgery
• Known cervical pathology
• Taking any medication except for occasional analgesics.
Intervention groups
• Temporomandibular Joint Mobilization Group (Group I)
• Control Group (Group II)
Main outcome variables
• Pain
• Range of Motion
• Functional Disability
General information
Reason for update
Acronym
TMJ
IRCT registration information
IRCT registration number:IRCT20210913052456N1
Registration date:2022-02-02, 1400/11/13
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Naveeda Ashraf
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 35440889
Email address
naveedaashraf123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-25, 1400/08/03
Expected recruitment end date
2022-06-25, 1401/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
IMMEDIATE AND PROLONGED EFFECTS OF TEMPOROMANDIBULAR JOINT MOBILIZATION ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN HYPOMOBILE TEMPOROMANDIBULAR JOINT PATIENTS; A RANDOMIZED CONTROLLED TRIAL
Public title
Immediate and prolong effects of manual therapy on Jaw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Pain in the region of the Temporomandibular joints and masticatory
• Associated muscles and limited mandibular movement for at least six months
• Complete dentition to provide stable and repeatable base points for jaw measurements.
• Diagnosed by an experienced clinician as suffering from Temporomandibular disorders
• Decreased mandibular opening
Exclusion criteria:
• History of severe head trauma or surgery
• Known cervical pathology
• Taking any medication except for occasional analgesics.
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
Purposive sampling
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization with Sealed Envelops will be given by the assessor after pre-treatment assessment Odd number will be given to the control group and Even numbers will be given to the treatment
group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor have been blinded by simply not informing him of the group allocation of the participants. After Assessment the assessor will be asked to handover the sealed envelope with a number written on the envelope. The Assessor was not aware of the random numbers and group allocation. Every odd number will be then allocated to control group by the therapist and every even number will be allocated to intervention group by the therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Lahore, Faculty of Allied health Science, Institutional Review Board
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IRB-UOL-FAHS/761/2020
Health conditions studied
1
Description of health condition studied
temporomandibular joint disorder
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
• Pain
Timepoint
4 weeks
Method of measurement
Visual Analogue Scale
2
Description
• Range of Motion
Timepoint
4 weeks
Method of measurement
Goniometer, Vernier Calliper
3
Description
Functional disability
Timepoint
4 weeks
Method of measurement
Jaw disability index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will get on spot session of 30 minutes session of manual therapy. Mulligan technique will be applied
Category
Rehabilitation
2
Description
Control group: Transcutaneous Electrical Neuromuscular Stimulation, Hot pack and soft tissue technique will be applied to the patients
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University institute of physical therapy, The University of Lahore,
Full name of responsible person
Dr. Ashfaq Ahmad
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Phone
+92 42 35321761
Email
ashfaq.ahmad@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmad
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Postal code
54700
Phone
+92 42 35321761
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Self Support
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Naveeda Ashraf
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 333 4888279
Email
naveeda.ashraf@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35440889
Email
umber.nawaz@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Umber Nawaz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54700
Phone
+92 42 35440889
Email
umber.nawaz@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IMMEDIATE AND PROLONGED EFFECTS OF TEMPOROMANDIBULAR JOINT MOBILIZATION ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN HYPOMOBILE TEMPOROMANDIBULAR JOINT PATIENTS; A RANDOMIZED CONTROLLED TRIAL
When the data will become available and for how long
After Publication the data will be available for 5 years
To whom data/document is available
To researcher
Under which criteria data/document could be used
Data will be accessible to the researchers on request at naveeda.ashraf@uipt.uol.edu.pk
From where data/document is obtainable
communication and clear contact information such as
email addresses mentioned previously along with cover
letter and resume and purpose of the data need.
What processes are involved for a request to access data/document
Requested email to the following addresses:
naveeda.ashraf@uipt.uol.edu.pk
umber.nawaz@uipt.uol.edu.pk